Beckman Coulter Inc Synchron LX Clinical Systems Software Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron LX Clinical Systems Software
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All Software versions.
Products Sold
All Software versions.
Beckman Coulter Inc is recalling Synchron LX Clinical Systems Software due to 'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information, corrective action details.
Reason for Recall
As stated by FDA
'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026